RE: [IHE-Pharmacy:3413] Slide deck for adverse event reporting
Michael Tan
Hello Christian,
This part of the process is the phase before you can send the ICSR to WHO. It is gathering the data for the National Body from the different sources. The National Body then prepares and verifies the data, transforms the codes to MedDRA before sending it with an ICSR message to Uppsala.
On slide 8 it is the left part of the data flow from the National body. ICSR is the right part from National body to WHO.
It is Jose that initiated this quest and we will discuss it this Friday on our IHE Pharmacy Technical committee call. Jose has mentioned that the WHO has interest in ADE and we are in the attempt to create a project with funding. I have tried this project earlier ( in 2018) but did not succeed then. Perhaps now with the experience of Covid there might be more willingness to get this started.
Are you interested to join the call, so that we can understand any possible overlap?
With kind regards,
Michael Tan FHL7, product manager Nictiz
Postbox 19121 | 2500 CC Den Haag | Oude Middenweg 55 | 2491 AC Den Haag
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Van: ihe-ph...@googlegroups.com <ihe-ph...@googlegroups.com>
Namens H...@medinorma.ch
Verzonden: maandag 28 maart 2022 16:30
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Onderwerp: RE: [IHE-Pharmacy:3413] Slide deck for adverse event reportingMarc Robberecht <marc.ro...@dedalus.com>
HI Michael, all,
This is an interesting slide deck -thanks for sharing.
I would like to understand how that plays with the current systematic review of the ICSR standards, which we will discuss at ISO in June… knowing that several stakeholders have requested to NOT change ICSR at this point of time.
This said, your slide deck is not only covering that aspect of ADE reporting, and I personally think there is space for improvement outside ICSR -since we know the gap between data collection in the clinical space and the regulatory space (ICSR), just to name an example.
I look forward reading more about this
Best wishes
Christian Hay
Managing Partner
Medinorma LLC
Grand Rue 34
1180 Rolle
Switzerland
Phone : +41 21 8253219
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De la part de Michael Tan
Envoyé : lundi, 28 mars 2022 16:21
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Objet : [IHE-Pharmacy:3412] Slide deck for adverse event reportingMarc Robberecht <marc.ro...@dedalus.com>
Hello Jose,
I have prepared a slide presentation on the business case of Adverse Event Reporting for the WHO. Could we discuss this on the IHE Pharmacy Technical Committee call this Friday?
With kind regards,
Michael Tan
product manager Nictiz
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h...@medinorma.ch
Hi Michael
Thank you for this. That is really interesting.
I have planed that you or José will present shortly what is on IHE pharmacy’s agenda, at our June ISO meeting (which I understand you will attend).
That’s mostly to complete the ICSR systematic review process and the resolution WG6 will be required to adopt.
Could you perhaps re-send me the meeting invitation for tomorrow ?
Kind regards
Christian Hay
Managing Partner
Medinorma LLC
Grand Rue 34
1180 Rolle
Switzerland
Phone : +41 21 8253219
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De : ihe-ph...@googlegroups.com <ihe-ph...@googlegroups.com> De la part de Michael Tan
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Objet : RE: [IHE-Pharmacy:3414] Slide deck for adverse event reporting
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Michael Tan
Op 31 mrt. 2022 om 10:50 heeft h...@medinorma.ch het volgende geschreven:
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SPAHNI Stéphane
Hello,
There is a tecnical committee call tomorrow? I cannot see it on the WIKI (nor on the schedule file in the google drive)!
I will not be available - I have meetings from 09:00 to 15:00 :-(
Stéphane
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Stéphane Spahni, PhD
Systems Architect
University Hospitals of Geneva
Division of eHealth and telemedicine
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Michael Tan
Hello Stpehane,
Yes, I see you are right. It is not mentioned in the schedule, and there is no minutes of the last technical call of March.
I think it is scheduled because I used the repeating function of the calendar. We planned to have a F2F in April, but I understand that is is not feasible.
Anyway since I have invited Christian to the call to discuss the Adverse Event potential, I will certainly be present.
It would be good if Jose could join as well.
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